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RSV Vaccine formulation 1

Phase 2

Respiratory Syncytial Virus Infections | Monoclonal antibody | Respiratory |GSK plc|Last Updated: Jul 2, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment406
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02956837A Study to Rank Different Dosages of Antigen of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3003891A), Based on Their Immune Response and Safety, When Administered to Healthy Adult WomenPHASE2 COMPLETED 406Nov 10, 2016Feb 5, 2018Jul 2, 20198 Belgium, Estonia +2
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Study Endpoints
Primary Endpoints
Number of Subjects With Any Grade 2 and Grade 3 General Adverse Events (AEs) - Solicited and Unsolicited
During the 7-day (Days 0-6) post-vaccination period

Assessed solicited general AEs were fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhea and/or abdominal pain\], fever and headache. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.Grade 2 symptoms = occurrence of symptoms discomforting enough to interfere with daily activities. Grade 3 symptoms = symptoms that prevented normal activities. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).

Number of Subjects With Grade 2 and Grade 3 Fever
During the 7-day (Days 0-6) post-vaccination period

Grade 2 Fever was defined as oral temperature above (\>) 38.5 degrees Celsius (°C) to less than or equal to (≤) 39.5°C. Grade 3 Fever was defined as oral temperature \> 39.5°C. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).

Number of Subjects With Related Serious Adverse Events (SAEs)
During the 7-day (Days 0-6) post-vaccination period

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Related SAEs = SAEs assessed by the investigator as related to the vaccination. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).

Neutralizing Antibody Titers Against RSV-A Subtype
At Day 0

RSV-A is one of the two antigenically distinct subgroups of the Respiratory Synctial Virus (RSV). Antibody titers were determined by neutralization assay and presented as geometric mean titers (GMTs), for a seropositivity cut-off value greater than or equal to (≥) 8 ED60 (Estimated Dilution 60). This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).

Palivizumab Competing Antibody (PCA) Concentrations
At Day 0

PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).

Pavilizumab Competing Antibody (PCA) Concentrations
At Day 30

PCA concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL), for a seropositivity cut-off ≥ 9.6 µg/mL. This primary objective focused only on subjects from the investigational GSK3003891A vaccine groups (GSK3003891A vaccine formulation 1 Group, GSK3003891A vaccine formulation 2 Group and GSK3003891A vaccine formulation 3 Group).

Secondary Endpoints
Number of Subjects With Any, Grade 2, Grade 3 and Medically Attended Solicited Local AEs
During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any, Grade 2, Grade 3, Related and Medically Attended Solicited General AEs
During the 7-day (Days 0-6) post-vaccination period
Number of Subjects With Any Unsolicited AEs
During the 30-day (Days 0-29) post-vaccination period
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
GSK3003891A vaccine formulation 1 GroupEXPERIMENTALSubjects in this group received a single 30 micrograms (µg) dose injection of the investigational GSK3003891A vaccine at Day 0.
GSK3003891A vaccine formulation 2 GroupEXPERIMENTALSubjects in this group received a single 60µg dose injection of the investigational GSK3003891A vaccine at Day 0.
GSK3003891A vaccine formulation 3 GroupEXPERIMENTALSubjects in this group received a single 120µg dose injection of the investigational GSK3003891A vaccine at Day 0.
Control GroupPLACEBO_COMPARATORSubjects in this group received a single placebo injection at Day 0.
Interventions
NameTypeDescription
RSV Vaccine (GSK3003891A) formulation 1BIOLOGICALSingle dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
RSV Vaccine (GSK3003891A) formulation 2BIOLOGICALSingle dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
RSV Vaccine (GSK3003891A) formulation 3BIOLOGICALSingle dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
Placebo (Formulation buffer S9b)DRUGA single dose of placebo is administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexFEMALE
Healthy VolunteersYes
Study Sites8

Inclusion Criteria: * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject prior to performance of any study specific procedure. * Non-pregnant female between, and including, 18 and 45 years...

Countries:BelgiumEstoniaFranceGermany
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